Basically, even though the FDA specifically disapproved of the Impossible Burger’s key ingredient (soy leghemoglobin) for human consumption, expressing concerns that it may be an allergen, it came to light thatthe FDA’s approval was never even required in the first place, since food manufacturers can self-affirm ingredients as being safe under the agency’s GRAS (Generally Recognized as Safe) program. According to Pew Charitable Trusts, the FDA is unaware of some 1,000 out of 10,000 ingredients used in food, because companies self-affirmed their safety. Now, since the Impossible Burger hasn’t been recalled and is still being sold, it’s creating alarming awareness thatthere are many ingredients on the market that the FDA isn’t even aware of.The way this unfolds could drastically change the landscape of food innovation, especially as bio-engineering technologies become bolder and more sophisticated.

So, what is the Impossible Burger? The entire premise of the Impossible Burger is that it’s a burger engineered to replicate every aspect of the traditional burger experience. Taste, texture, sight, scent, feel, and even thesound.Yes, really, it goes that deep. As far as all of your senses are concerned, it’s a regular good old burger. The one key difference, though, is that it’s madeentirelyfrom natural and plant-based ingredients, and thus it is healthier and more sustainable [1].

In these ingredients, you’ll find no hormones, no antibiotics, and no artificial ingredients. Notice something else missing? That’s right…no meat!

Sounds crazy, right? Their special ingredient is a protein known as “heme”. It’s released from soy leghemoglobin when it breaks down, and this supposedly gives the burger a unique meat-like taste and texture. Impossible Foods claims that this ingredient is completely safe, based on all of the tests they’ve done… but the FDA disagrees, claiming that the company’s assessment of the potential for the ingredient to be an allergen wasdeficient [3]. Even though Impossible Foods technically didn’t have to get the FDA’s approval to use the ingredient, they sought it anyway, perhaps for the sake of transparency. But like I said, the FDA couldn’t give their nod of approval.Which brings to light a massive issue that makes a lot of people uncomfortable…might we have been eating foods without FDA approval all this time? Moreover, might we have been eating foods all this time that werespecifically disapprovedby the FDA, but they were sold anyway?

Yikes. These are scary thoughts to the average person.

According to a New York Times piece that covered this issue,most new ingredients don’t require the FDA’s approval at all. Though action “could” be taken, as the agency sees appropriate…

"The F.D.A.’s approval is not required for most new ingredients. Companies can hire consultants to run tests, and they have no obligation to inform the agency of their findings, a process known as self-affirmation. —

Companies have “no requirement” to notify the F.D.A. of a food being determined safe, Megan McSeveney, an agency spokeswoman, said in an email. She added, however, that the F.D.A. could question the basis for any such conclusion and “take appropriate action to protect public health.”

Now, why the lack of regulation? It’s for a very good reason. According to the same New York Times piece, 20 years after the FDA was given the power to police food additives in 1938, the agency added an exemption wherecompanies could sell products without the agency’s review if the additives were deemed safe. According to Tom Neltner (chemicals policy director at the Environmental Defense Fund), this has been exploited by food companies…

The exemption was meant to cover ingredients that had long been used in the food supply, so that companies didn’t have to come in every time they made a new product. It wasn’t meant to allow companies to simply bypass the F.D.A.

In a 2013 study done by the Pew Charitable Trusts, the FDA wasunaware of roughly 1,000 of 10,000 ingredients used in food, because companies had used the self-affirmation process. This launched legal action by the Center for Food Safety against the FDA, who has supposedly neglected closing this gap in the law [4].

It’s right for there to be controversy about this, in my opinion. But it has a lot more to do with the FDA than it does Impossible Foods. The Impossible Burger is one of many examples of food that is available in the United States that didn’t undergo regulatory scrutiny, and that is bound to make a lot of consumers anxious. That’s where the controversy comes from. The FDA didn’t approve the key ingredient of the Impossible Burger, the approval didn’t need to be sought in the first place, they sold the Impossible Burger anyway, and it’s completely legal.

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